FDA Orange Book
Generic for Xifaxan
Xifaxan contains rifaximin. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Xifaxan is rifaximin. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Xifaxan products the Orange Book lists.
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Xifaxan products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 200MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 550MG | Marketed (Rx) | AB | 1 | AB |
NDA 021361, held by SALIX PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic rifaximin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACTAVIS LABORATORIES FL INC | 208959 | AB (A-rated, therapeutically equivalent) | March 19, 2026 | 550MG |
Xifaxan patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10703763 | February 27, 2026 | Method of use | U-2848 | 021361 |
| 8741904 | February 27, 2026 | Drug substance, Drug product | U-2848 | 021361 |
| 8518949 | February 27, 2026 | Drug product | None | 021361 |
| 9271968 | February 27, 2026 | Drug product | None | 021361 |
| 8741904 | February 27, 2026 | Drug substance, Drug product | U-1708 | 021361 |
| 8741904 | February 27, 2026 | Drug substance, Drug product | U-1707 | 021361 |
| 10703763 | February 27, 2026 | Method of use | U-2847 | 021361 |
| 10703763 | February 27, 2026 | Method of use | U-1708 | 021361 |
| 8741904 | February 27, 2026 | Drug substance, Drug product | U-2847 | 021361 |
| 8193196 | September 2, 2027 | Drug substance, Drug product | None | 021361 |
| 8193196 | September 2, 2027 | Drug substance, Drug product | U-1707 | 021361 |
| 8193196 | September 2, 2027 | Drug substance, Drug product | U-1708 | 021361 |
| 10456384 | February 26, 2029 | Method of use | U-2643 | 021361 |
| 10456384 | February 26, 2029 | Method of use | U-2644 | 021361 |
| 10765667 | February 26, 2029 | Method of use | U-2644 | 021361 |
| 10765667 | February 26, 2029 | Method of use | U-2643 | 021361 |
| 11779571 | February 26, 2029 | Method of use | U-3706 | 021361 |
| 11564912 | February 26, 2029 | Method of use | U-3511 | 021361 |
| 11564912 | February 26, 2029 | Method of use | U-3512 | 021361 |
| 8309569 | July 18, 2029 | Method of use | U-1708 | 021361 |
| 8309569 | July 18, 2029 | Method of use | U-1707 | 021361 |
| 7928115 | July 24, 2029 | Method of use | U-1121 | 021361 |
| 8829017 | July 24, 2029 | Method of use | U-1562 | 021361 |
| 9421195 | July 24, 2029 | Method of use | U-1481 | 021361 |
| 8946252 | July 24, 2029 | Method of use | U-1481 | 021361 |
| 10335397 | July 24, 2029 | Method of use | U-2579 | 021361 |
| 9629828 | July 24, 2029 | Method of use | U-1994 | 021361 |
| 10314828 | July 24, 2029 | Method of use | U-1481 | 021361 |
| 10709694 | July 24, 2029 | Method of use | U-2579 | 021361 |
| 8642573 | October 2, 2029 | Method of use | U-1481 | 021361 |
| 8969398 | October 2, 2029 | Method of use | U-1481 | 021361 |
Xifaxan NDC codes
Questions
Is there a generic for Xifaxan?
Yes. The generic name for Xifaxan is rifaximin. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Xifaxan products the Orange Book lists.
What is the generic name for Xifaxan?
The active ingredient in Xifaxan is rifaximin, per the FDA Orange Book.
When does the Xifaxan patent expire?
The last patent listed for Xifaxan in the Orange Book expires October 2, 2029. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.